Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors

Xencor

Status and phase: Not yet enrolling; Phase 1

Conditions: Ovarian Cancer

Treatments: Biological: XmAb808; Biological: XmAb541

Study type: Interventional

Funder types: Industry

Identifiers

NCT07593092

XmAb541-02

Details and patient eligibility

About

The primary purpose of this study is to determine whether the investigational drug XmAb541 in combination with XmAb808 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 in combination with XmAb808 on tumor outcomes.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• CLDN6+ tumor
• Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin
• Adequate Eastern Cooperative Oncology Group performance status
• Life expectancy ≥ 3 months
• Adequate organ function

Exclusion criteria

• Prior exposure to a CLDN6 targeting immune cell engager
• Patients with treated brain metastases may participate, provided they are radiologically stable.
• Active known or suspected autoimmune disease
• Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
• Clinically significant cardiovascular, pulmonary or gastrointestinal disease
• Active viral hepatitis B or hepatitis C

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Dose Escalation and Dose Expansion of XmAb541 and XmAb808

Experimental group

Treatment:

Biological: XmAb541

Biological: XmAb808